NCT03719365: DPNAVA

Driving Pressure Variation: NAVA vs PSV

Status unknown NA Last updated 12 April 2019

What this trial tests

NA trial testing NAVAPSV in Mechanical Ventilation Complication in 20 participants. Status unknown.

Timeline

1 November 2018

Primary endpoint
1 December 2019

1 November 2020

Quick facts

Lead sponsor	Azienda Ospedaliero Universitaria Maggiore della Carita
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	supportive care
Enrollment	20
Start date	1 November 2018
Primary completion	1 December 2019
Estimated completion	1 November 2020
Sites	1 location across Italy

Drugs / interventions tested

• NAVAPSV

Conditions studied

• Mechanical Ventilation Complication — all drugs for Mechanical Ventilation Complication →
• Ventilator-Induced Lung Injury — all drugs for Ventilator-Induced Lung Injury →

Sponsor

Azienda Ospedaliero Universitaria Maggiore della Carita — full company profile →

Who can join

18 and older, any sex, with Mechanical Ventilation Complication or Ventilator-Induced Lung Injury. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Assisted ventilation represents, nowadays, the preferred ventilation mode in clinical practice.It has been shown that assisted ventilation modes improve ventilation/perfusion matching, descrease risk of Ventilator induced lung injury and muscle atrophy and have less influence on haemodynamic function.

However, PSV (Pressure Support Ventilation) is not free from complications: it may worsen or cause lung injuries by increasing alveolar and intrathoracic negative pressure and by loosing control on Tidal Volume (Vt). Indeed, it has been demonstrated that Vt is the main factor related to VILI.

It has been shown that lower Vt and higher PEEP can improve clinical outcome only if associated with a simultaneous reduction in Driving Pressure. Increase in Driving Pressure resulted strongly associated with negative outcomes, especially if higher than 15 cm H2O.

PSV is currently the most used assisted ventilation mode. NAVA (Neurally Adjusted Ventilatory Assist) is a ventilation mode in which the diaphragmatic electrical activity (EAdi) is used as a trigger to start a mechanical breath, applying positive pressure during patient's inspiration. Diaphragmatic electrical activity (EAdi) can be detected by a particular nasogastric tube (EAdi catheter). EAdi is the currently available signal closest to the neural breathing centers, which can estimate the patient's respiratory drive, if phrenic nerves are not damaged. It has been demonstrated that NAVA ventilation can reduce the incidence of patient-ventilator asynchronies, because the delivery of the support and the cycling between inspiration and expiration are completely controlled by the patient.

However, although PSV and NAVA have been widely compared in many investigations, up to now there are no studies about driving pressure variation during these two modalities of mechanical assisted ventilation. The aim of this study is to measure changes in driving pressure at different levels of ventilatory assistance in PSV and NAVA ventilation modes.

Secondary end points are respiratory mechanics indices and patient/ventilator related asynchrony evaluation and comparison.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Effects of Varying Levels of Inspiratory Assistance with Pressure Support Ventilation and Neurally Adjusted Ventilatory Assist on Driving Pressure in Patients Recovering from Hypoxemic Respiratory Failure.
   Cammarota G, Verdina F, De Vita N, Boniolo E, et al · · 2022 · cited 6× · PMID 33559864 · DOI 10.1007/s10877-021-00668-2